Acetylated Natural Nucleotides in Treating Hand-foot Syndrome
China21 participantsStarted 2020-11-03
Plain-language summary
The clinical trial is planned to investigate the efficacy and safety of acetylated natural nucleotides in treating anti-cancer medications induced hand-foot syndrome (HFS).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years of age or older.
* Pathologically confirmed cancer receiving capecitabine-based anti-cancer therapy (capecitabine with or without other anti-cancer drugs).
* With HFS determined by "CTCAE v5.0 - PPE" as grade 2 or above.
* Able to use topical medications and complete questionnaires reliably with or without assistance.
* ECOG performance score \< 2.
Exclusion Criteria:
* Has HFS due to other medications and does not recover within 4 weeks prior to baseline.
* Other skin disorders that will affect efficacy evaluation on the hands and feet, including but not limited to: tinea of feet and hands, hand/foot eczema, palmoplantar pustulosis, palmoplantar keratosis, acrodermatitis continua etc.
* Uncontrolled intercurrent illness as determined by the investigator including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, uncontrolled hypotension or hypertension, cardiac arrhythmia, or psychiatric illness and social situations that would limit compliance with study requirements.
* Significantly abnormal lab test:
* Inadequate hematologic function as indicated by:
* Absolute neutrophil counts (ANC) \< 1,500 /mm\^3
* Hemoglobin (Hgb) \< 8.5 g/dL
* Platelet count \< 75,000 /mm\^3
* PT or PTT \> 1.5 x ULN (if patients on anticoagulants: PT INR \> 3.5 x ULN)
* Inadequate renal and liver function as indicated by:
* Albumin \< 2.8 g/dL
…
What they're measuring
1
Proportion of patients who achieve "NCI CTCAE v5.0 - Palmar-Plantar Erythrodysesthesia (PPE)" grade 0 or 1